EU → North America Device Access

Lohmann & Rauscher International GmbH & Co. KG

DE-MF-000005052 · Germany · Rengsdorf

Lohmann & Rauscher International GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 111 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa105
Class IIb6

Most frequent device types declared: Gauze Swabs, invasive, sterile, Impregnated Gauze Mesh, Nonwoven cellulose wound pads, Raucodrape Accessories as single product: adhesive tapes/strips, Raucodrape OR Drapes.

Among these devices, 95 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 111 declared devices.

Catalogue references include 33062, 33083, 33307, 33368, 33661, 33841.

European nomenclature codes declared: T020199, T0202, M0201020101, M040204, M02030201, M03030201.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED111
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN111
Found in the U.S. device database2
Share1.8 %
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryLOHMANN & RAUSCHER INTERNATIONAL GMBH & CO. KG

What it holds in Canada

Licences on record5
Currently active0
Class 2 devices5
First licensed2020-09-15

Licence types: Device Family (3), Single Device (2).

Licensed under: DEBRISOFT PAD, DEBRISOFT LOLLY, DEBRISOFT, VLIWASORB, VLIWASORB ADHESIVE.

North American profile: Canada only. Lohmann & Rauscher International GmbH & Co. KG holds a Canadian licence but was not found in the U.S. register.

Other manufacturers in Germany

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